Trunk Proprioception in Adolescent Idiopathic Scoliosis

NCT05326256 | Completed DMC

• 1 other identifier: 2022/008
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Aims of this clinical research:

• To investigate trunk proprioception in all three planes in individuals with adolescent idiopathic scoliosis (AIS),
• To investigate the pelvis orientation sense in all three planes in individuals with adolescent idiopathic scoliosis,
• To investigate whether trunk proprioception and pelvis orientation sense are improved with Physiotherapy Scoliosis Specific Exercises (PSSE) in AIS,
• To investigate whether trunk proprioception and pelvis orientation sense are improved with vestibular exercise training to be added to PSSE exercises in AIS,
• Comparison of the effects of different exercise training on trunk proprioception and pelvis orientation sense in AIS
• To examine the parameters that may be associated with the improvement of trunk proprioception of different exercise training (health-related quality of life, perception of cosmetic deformity, scoliosis-related clinical features such as Cobb angle, axial trunk rotation, curve type, etc.).

Conditions

Scoliosis Idiopathic; Scoliosis; Adolescence

Keywords

scoliosis; adolescent; proprioception; exercise

Outcome Measures

Primary Outcomes (7)

• Change of Trunk Proprioception

  Thoracic position sense is measured by active angle reproduction using GyKo (Microgate, Bolzano, Italy) inertial system. The system component is located on the trunk at the level of C7-T1 vertebrae. The individual to be measured is standing, for example, the individual to flexion the trunk to 30 degrees and is shown to target angle. Then, the individual is asked to close his eyes and come to the target angle actively. The measurement is repeated 3 times. All data are read from the screen.

  Baseline, after the 12 weeks of exercise training

• Change of Pelvis Orientation Sense

  Pelvis orientation sense is measured by active angle reproduction using GyKo (Microgate, Bolzano, Italy) inertial system. The system component is located on the lumbar area at the level of the S1 vertebrae. The individual to be measured is standing, performs the anterior-posterior pelvic tilt motion in her/his pelvis, and is shown to target angle. Then, the individual is asked to close his eyes and come to the target angle actively. The measurement is repeated 3 times. All data are read from the screen.

  Baseline, after the 12 weeks of exercise training

• Change of Dynamic balance, spatial orientation

  Assement of dynamic balance with Fukuda-Utenberger stepping test

  Baseline, after the 12 weeks of exercise training

• Change of Cosmetic Deformity Perception

  Perception of cosmetic deformity assessment with Walter Reed Visual Evaluation Scale and Turkish version of The Spinal Appearance Questionnaire (SAQ)

  Baseline, after the 12 weeks of exercise training

• Change of Cosmetic Deformity Perception according to Individual, Parent and Physiotherapist

  Perception of cosmetic deformity assessment with Turkish version of The Spinal Appearance Questionnaire (SAQ)

  Baseline, after the 12 weeks of exercise training

• Change of Health-Related Quality of Life

  Health-Related Quality of Life Assessment with Turkish version of Scoliosis Research Society-22 (SRS-22) Questionnaire

  Baseline, after the 12 weeks of exercise training

• Change of Body Asymmetry

  Body asymmetry assessment with POTSI (Postural Trunk Symmetry Index)

  Baseline, after the 12 weeks of exercise training

Secondary Outcomes (7)

• Enroll of the Cobb Angle

  Baseline, after the 12 weeks of exercise training

• Enroll of the Risser sign

  Baseline, after the 12 weeks of exercise training

• Enroll of the clinical features of scoliosis

  Baseline, after the 12 weeks of exercise training

• Change of Angle of Trunk Rotation

  Baseline, after the 12 weeks of exercise training

• Change of Pain

  Baseline, after the 12 weeks of exercise training

Other Outcomes (1)

• Change of Quality of Life according to brace- The Brace Questionnaire

  Baseline, after the 12 weeks of exercise training

Study Arms (2)

PSSE Group

EXPERIMENTAL

Physiotherapy Scoliosis Specific Exercises (PSSE), 45-minute exercise session with the supervisor, twice a week for 12 weeks

Other: Exercise training- PSSE

Vestibular Exercise Group

EXPERIMENTAL

Vestibular exercises to be added to PSSE exercises, 45-minute exercise session with the supervisor, twice a week for 12 weeks

Other: Exercise training- PSSE with vestibular exercises

Interventions

Exercise training- PSSE OTHER

Barcelona Scoliosis Physical Therapy School (BSPTS) method exercises

PSSE Group

Exercise training- PSSE with vestibular exercises OTHER

Vestibular exercises added to Barcelona Scoliosis Physical Therapy School (BSPTS) exercises

Vestibular Exercise Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with adolescent idiopathic scoliosis,
• Aged 10-18,
• Have Physiotherapy Scoliosis Specific Exercises (PSSE) indications,
• Individuals and her/his parents volunteered to participate in the study.

You may not qualify if:

• Any contraindication that will prevent the individual from participating to exercise training,
• Have had spinal surgery before,
• Have any mental problems,
• The fact that scoliosis is not idiopathic but has arisen for different reasons (neurological, congenital, etc.),
• The apex of the curve is thoracal-6 vertebrae and above,
• Any neurological, psychiatric, muscular, rheumatic, renal, cardiovascular, pulmonary, tumoral, or orthopedic disease.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants in the training groups and the statistical assessor will not be informed about which group the individuals belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: April 13, 2022
• Study Start: February 2, 2022
• Primary Completion: February 2, 2023
• Study Completion: April 17, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

TU (1)